Received Mar 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
a week after received GARDASIL 9 she experienced an off cycle period, approximately 14 days after her last period.; injection site pain; Caller also mentioned having lasik done; This spontaneous report was received from a Patient (Company Representative) and refers to herself, a 36-year-old female patient. The patient's medical history included ovarian cyst removed (in March 2024). The patient's concurrent conditions included Augmentin and Tramadol allergy. Historical drugs included Augmentin (Amoxicillin sodium; Clavulanate potassium), and Tramadol (Tramadol). Concomitant therapies were not reported. On 21-JAN-2026, she went for her annual physical and confirmed she was not pregnant. Her last menstrual period was on 23-JAN-2026. On 29-Jan-2026, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Suspension for injection, dose number 1, (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. In 2026, the patient experienced injection site pain (vaccination site pain). On approximately 05-Feb-2026 (a week after vaccination), the patient experienced an off cycle period, approximately 14 days after her last period (polymenorrhoea). She stated her last menstrual cycle was on 23-JAN-2026 and her next period began on 26-FEB-2026 (conflicting information). The reporter stated she informed her physician on the early period and was advised to monitor flow and if it gets worse to go to the emergency department (ER). Caller stated she was no longer on her period and her next expected period was in "the later part of a week or so". She also mentioned having lasik done (on an unspecified date in 2026) (keratomileusis). The reporter stated she was scheduled to receive her second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) the next day (reported as tomorrow). The patient recovered from the event of polymenorrhoea in 2026. At the reporting time, the outcome of vaccination site pain and keratomileusis was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was reported as not applicable. The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided. Lot # is being requested and will be submitted if received.
Drug allergy
Medical History/Concurrent Conditions: Ovarian cystectomy